UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


 

FORM 8-K

 


 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): March 16, 2017

 

Stemline Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware
(State or Other Jurisdiction
of Incorporation)

 

001-35619
(Commission File Number)

 

45-0522567
(IRS Employer Identification No.)

 

750 Lexington Avenue

Eleventh Floor

New York, New York 10022

(Address of Principal Executive Offices)

 

(646) 502-2311

(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o Written communications pursuant to Rule 425 under the Securities Act.

 

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act.

 

o Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act.

 

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

 

 

 



 

Item 2.02. Results of Operations and Financial Condition.

 

On March 16, 2017, Stemline Therapeutics, Inc. issued a press release to provide a corporate update and to announce its financial results for the fourth quarter ended December 31, 2016. A copy of such press release is being furnished as Exhibit 99.1 to this report.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

The following exhibit is furnished herewith:

 

Exhibit
Number

 

Description

99.1

 

Press release issued by Stemline Therapeutics, Inc., dated March 16, 2017.

 

2



 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: March 17, 2017

Stemline Therapeutics, Inc.

 

(Registrant)

 

 

 

 

 

By

/s/ Kenneth Hoberman

 

 

Kenneth Hoberman

 

 

Chief Operating Officer

 

3



 

INDEX TO EXHIBITS

 

Exhibit
Number

 

Description

99.1

 

Press release issued by Stemline Therapeutics, Inc., dated March 16, 2017.

 

4


Exhibit 99.1

 

 

Stemline Therapeutics Reports Fourth Quarter 2016 Financial Results

 

NEW YORK, NY, March 16, 2017 (GLOBE NEWSWIRE)—Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology indications of unmet medical need, announced today financial results for the quarter ended December 31, 2016. The company also reviewed clinical and regulatory events from the past quarter, and outlined key upcoming milestones:

 

SL-401 In Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

 

·                  SL-401 Phase 2 clinical trial results in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) delivered as an oral presentation at the 2016 American Society of Hematology (ASH) annual meeting.

 

·                  After receipt of breakthrough therapy designation in 3Q16, Stemline had a successful meeting with the U.S. Food and Drug Administration (FDA) resulting in a defined registration pathway for possible full approval in first-line BPDCN.

 

·                  Stemline is currently enrolling patients in a new cohort (Stage 3) that is expected to enroll approximately 8-12 first-line BPDCN patients.

 

·                  Completion of enrollment of the Stage 3 cohort expected this quarter. We plan to provide clinical results from this cohort in the second half of this year.

 

Additional Clinical Trials

 

·                  SL-401 is being clinically evaluated in several additional indications including certain high-risk myeloproliferative neoplasms (MPN), acute myeloid leukemia (AML) in complete remission with minimal residual disease, and with relapsed/refractory multiple myeloma. SL-801 is being evaluated in a Phase 1 dose escalation trial of advanced solid tumor patients. SL-701 has completed dosing in a Phase 2 trial in second-line glioblastoma. Updates from these studies are expected this year.

 

Fourth Quarter 2016 Financial Results Review

 

Stemline ended the fourth quarter of 2016 with $67.6 million in cash, cash equivalents and investments, as compared to $74.3 million as of September 30, 2016, which reflects a cash burn of $6.7 million for the quarter.  Subsequent to year end 2016, Stemline completed a follow-on public offering during January 2017 raising $48.2 million in net cash proceeds bringing total cash, cash equivalents and investments to approximately $110.0 million as of March 16, 2017.

 

For the fourth quarter of 2016, Stemline had a net loss of $10.0 million, or $0.56 per share, compared with a net loss of $10.2 million, or $0.58 per share, for the same period in 2015.

 

Research and development expenses were $7.3 million for the fourth quarter of 2016, which reflects a decrease of $0.6 million, or 8%, compared with $7.9 million for the fourth quarter of 2015.  The lower costs reflect a one-time payroll-related expense in 2015 partially offset by higher non-cash stock based compensation expense in 2016.

 

General and administrative expenses were $3.1 million for the fourth quarter of 2016, which reflects an increase of $0.5 million, or 19%, compared with $2.6 million for the fourth quarter of 2015. The increase in costs was primarily attributable to higher non-cash stock based compensation expense and the commencement of building infrastructure to support a potential commercial launch of SL-401 for

 



 

BPDCN.

 

About Stemline Therapeutics

 

Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel therapeutics for oncology indications of unmet medical need. A Phase 2 pivotal trial with SL-401, a targeted therapy directed to the interleukin-3 receptor (CD123), is enrolling patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an indication for which SL-401 has been granted Breakthrough Therapy Designation (BTD). Additional Phase 2 trials with SL-401 are enrolling patients with other malignancies including high-risk myeloproliferative neoplasms (MPN) and acute myeloid leukemia (AML) in remission with minimal residual disease (MRD). A Phase 1/2 trial of SL-401 in combination with pomalidomide is enrolling patients with relapsed/refractory multiple myeloma. A Phase 1 dose escalation trial is enrolling patients with advanced tumors with SL-801, a novel oral small molecule reversible inhibitor of XPO1. A Phase 2 trial with SL-701, an immunotherapy designed to activate the immune system to attack tumors, has completed dosing and patients with second-line glioblastoma are being followed for survival.

 

Forward-Looking Statements

 

Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The factors that could cause our actual results to differ materially include: the success and timing of our clinical trials and preclinical studies for our product candidates, including site initiation, internal review board approval, scientific review committee approval, patient accrual, safety, tolerability and efficacy data observed, and input from regulatory authorities including the risk that the FDA ultimately does not approve any of our product candidates; our plans to develop and commercialize our product candidates; market acceptance of our products; reimbursement available for our products; our available cash and investments; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to manufacture; the performance of third-party manufacturers, clinical research organizations, clinical trial sponsors and clinical trial investigators; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

 

Contact

 

Investor Relations

Stemline Therapeutics, Inc.

750 Lexington Avenue

Eleventh Floor

New York, NY 10022

Tel: 646-502-2307

Email: investorrelations@stemline.com

 



 

Table 1. Stemline Therapeutics, Inc. - Balance Sheets

 

 

 

December 31, 2016

 

December 31, 2015

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

10,316,064

 

$

13,376,196

 

Short-term investments

 

36,562,900

 

32,663,245

 

Prepaid expenses and other current assets

 

290,747

 

651,889

 

Total current assets

 

47,169,711

 

46,691,330

 

Furniture and fixtures, net

 

22,531

 

95,661

 

Long-term investments

 

20,714,551

 

51,428,632

 

Other Assets

 

212,305

 

 

Total assets

 

$

68,119,098

 

$

98,215,623

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued expenses

 

$

9,284,514

 

$

8,632,873

 

Current portion of deferred grant revenue

 

898,199

 

822,604

 

Other current liabilities

 

71,100

 

 

Total current liabilities

 

10,253,813

 

9,455,477

 

Deferred grant revenue, net of current portion

 

 

616,949

 

Other liabilities

 

142,200

 

31,241

 

Total liabilities

 

10,396,013

 

10,103,667

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock $0.0001 par value, 5,000,000 shares authorized, none issued and outstanding at December 31, 2016 and 2015

 

 

 

Common stock $0.0001 par value, 33,750,000 shares authorized at December 31, 2016 and 2015, 19,219,223 shares issued and outstanding at December 31, 2016 and 18,235,020 shares issued and outstanding at December 31, 2015

 

1,922

 

1,825

 

Additional paid-in capital

 

193,563,572

 

185,703,423

 

Accumulated other comprehensive loss

 

(99,802

)

(153,690

)

Accumulated deficit

 

(135,742,607

)

(97,439,602

)

Total stockholders’ equity

 

57,723,085

 

88,111,956

 

Total liabilities and stockholders’ equity

 

$

68,119,098

 

$

98,215,623

 

 



 

Table 2. Stemline Therapeutics, Inc. - Statements of Operations

 

 

 

Three Months Ended December 31,

 

Twelve Months Ended December 31,

 

 

 

2016

 

2015

 

2016

 

2015

 

Revenues:

 

 

 

 

 

 

 

 

 

Grant revenue

 

$

299,401

 

$

205,651

 

$

1,041,354

 

$

654,160

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

7,284,262

 

7,882,933

 

27,869,921

 

29,458,676

 

General and administrative

 

3,142,260

 

2,631,148

 

12,056,890

 

8,828,843

 

 

 

 

 

 

 

 

 

 

 

Total operating expenses

 

10,426,522

 

10,514,081

 

39,926,811

 

38,287,519

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(10,127,121

)

(10,308,430

)

(38,885,457

)

(37,633,359

)

 

 

 

 

 

 

 

 

 

 

Other (expense) income

 

(299

)

 

11,438

 

1,609

 

Interest income

 

128,606

 

128,824

 

545,718

 

387,889

 

 

 

 

 

 

 

 

 

 

 

Net loss before income taxes

 

$

(9,998,814

)

$

(10,179,606

)

$

(38,328,301

)

$

(37,243,861

)

 

 

 

 

 

 

 

 

 

 

Income tax (expense) benefit

 

(10,282

)

 

25,296

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(10,009,096

)

$

(10,179,606

)

$

(38,303,005

)

$

(37,243,861

)

 

 

 

 

 

 

 

 

 

 

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and Diluted

 

$

(0.56

)

$

(0.58

)

$

(2.15

)

$

(2.15

)

 

 

 

 

 

 

 

 

 

 

Weighted-average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and Diluted

 

17,885,113

 

17,562,559

 

17,804,681

 

17,289,021